Regulatory Affairs Specialist – Brazil

Company Description

At Regnova, we transform regulatory complexity into a catalyst for innovation and global growth. We help brands in pharmaceuticals, medical devices, nutraceuticals, cosmetics, and traditional medicine systems navigate compliance quickly and confidently. Blending regulatory expertise and AI-powered platforms like Regnova One, we empower businesses to accelerate product launches, expand into global markets, and maintain lifecycle compliance. With deep regional expertise and a robust network of partners, we redefine compliant innovation, turning complexity into momentum for a smarter, borderless future.

Role Overview:

ANVISA

Key Responsibilities:

• Prepare, review, and submit registration dossiers for

  pharmaceuticals, nutraceuticals, cosmetics, and/or medical devices

  to ANVISA.
• Maintain current product registrations and ensure timely renewals, amendments, and post-approval variations.
• Review labeling, packaging, and promotional materials for regulatory compliance (Portuguese labeling, INCI, claims).
• Liaise with ANVISA inspectors, local agents, and technical partners for submissions, clarifications, and audits.
• Ensure that importation documentation complies with RDC and other applicable resolutions.
• Monitor and interpret changes in ANVISA regulations; communicate implications internally.
• Support internal audits, quality system documentation, and regulatory due diligence for new products.
• Maintain accurate regulatory databases and submission trackers.

Requirements:

• Bachelor’s degree in

  Pharmacy, Biomedicine, Chemistry, Biotechnology, or related field

  .
• 3–5 years of regulatory experience in

  pharma, nutraceuticals, cosmetics, or medical devices

  .
• Proven experience in dossier compilation and ANVISA submission (RDC 185/01, RDC 240/18, RDC 222/06, etc. as applicable).
• Good understanding of GMP, GCP, and local technical requirements.
• Proficient in

  Portuguese and English

  (written and spoken).
• Strong organization and project management skills; experience in cross-functional coordination.

Preferred

• Experience working with multinational companies or local distributors for product registration.
• Familiarity with

  Mercosur regulations

  .
• Knowledge of electronic submission portals (Solicita, SEI).